ORC-13661 is a new chemical entity discovered and patented (US 9416141 and US 9493482 ) by University of Washington with grant assistance from NIH, and is exclusively licensed to Oricula Therapeutics LLC.
Preclinical testing of ORC-13661 has shown it provides almost 100% protection in rats dosed with the aminoglycoside antibiotic amikacin. Importantly, it has no interference with the bactericidal effects of aminoglycosides in several pathogenic bacteria. Dosing studies revealed oral bioavailability, linear pharmacokinetics over a wide range, and a half-life consistent with adequate coverage for once-a-day oral therapy. ORC-13661 passed GLP safety and toxicology studies.
An Investigation New Drug application was submitted to the FDA, and Oricula has been approved to move forward into human testing.